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Habitat Escalated Adaptive Therapy (HEAT) for High Grade Sarcoma

This study is looking at a new way to treat high-grade sarcoma, a type of cancer. It uses Intensity Modulated Radiation Therapy (IMRT), which is an FDA-approved radiation treatment. Before treatment, you will have an MRI (magnetic resonance imaging) scan. These MRI images help doctors find areas within the tumor that might be harder to treat with radiation. The goal is to see how well this approach, called HEAT, helps shrink the tumor. The study plans to enroll 43 participants aged 18 and older. The current status of the study is unclear.

Study design
This is an interventional study with a planned enrollment of 43 participants.
What's involved
You will receive pretreatment diagnostic MRIs and Intensity Modulated Radiation Therapy (IMRT).
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, "Rate of Favorable Pathologic Response," is measured at Week 10.

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NCT05301283

Habitat Escalated Adaptive Therapy (HEAT), With Neoadjuvant Radiation for Soft Tissue Sarcoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~43 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Intensity Modulated Radiation Therapy (IMRT)MRI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Favorable Pathologic Response (FPR)
Measured over Week 10

Conditions

High Grade Sarcoma

Explore related trials

Soft Tissue Sarcoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Arash O Naghavi, MD, MS · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

Inaya Lemus
[email protected]
813-745-4233
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
For women of childbearing potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 52 weeks after the end of radiation.
For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner 52 weeks after radiation.
Agreement to adhere to Lifestyle Considerations (as outlined in protocol) throughout study duration.
Pathologically (histologically or cytologically) proven diagnosis of high-grade (grade 2 or 3) Soft Tissue Sarcoma (STS) of the deep trunk and/or extremity. Clinical evidence should be documented, and may consist of pathology or imaging, and should be sufficient to estimate the size of the primary (for T stage)
Primary site deemed resectable prior to the start of trial
American Joint Committee on Cancer (AJCC) 8th edition staging T1-4 N0 M0, no evidence of distant metastases
Patients must have clinically or radiographically evident measurable disease at the primary site.
Pre-Radiation Therapy (RT) MRI within 4 weeks of the start of RT.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 3.
Deemed a surgical candidate
Participant agrees to blood and plasma preservation for future analysis.

Exclusion

Contraindications to an MRI
Positive urine pregnancy test
Gross total excision of primary STS, including an unplanned excision
Superficial sarcoma located primarily in the subcutaneous or cutaneous tissue
Prior radiation to the region of the study cancer that would result in overlap of radiation therapy fields.
Participants with a medical condition or social situation that, at the discretion of the principal investigator, would preclude them from completion of the trial.

What this trial measures

  • Rate of Favorable Pathologic Response (FPR)Week 10

    Percentage of participants with Favorable Pathologic Response (FPR): tumor necrosis \>/= 95% at time of surgery. FPR is associated with improved R0 resection rates, local control, distant control, and overall survival. Therefore, FPR acts as an early surrogate for outcome.